United States District Court, D. Delaware
PURDUE PHARMA L.P. et al., Plaintiffs,
MYLAN PHARMACEUTICALS INC. and MYLAN INC., Defendants.
REPORT AND RECOMMENDATION
R. FALLON, UNITED STATES MAGISTRATE JUDGE
before the court in this patent infringement action is a
motion to dismiss for failure to state a claim upon which
relief can be granted pursuant to Federal Rule of Civil
Procedure 12(b)(6), filed by defendants Mylan Inc.
("Mylan") and Mylan Pharmaceuticals Inc.
("MPI") (collectively, "defendants").
(D.I. 23) For the following reasons, I recommend that the
court deny the motion.
action arises out of defendants' submission of
Abbreviated New Drug Application ("ANDA") No.
203915 to the United States Food and Drug Administration
("FDA") on November 2, 2015. (D.I. 1 at
¶¶ 1> 31) Plaintiffs Purdue Pharma L.P., Purdue
Pharmaceuticals L.P., The P.F. Laboratories, Inc., and Rhodes
Technologies (collectively, "plaintiffs") assert
that defendants' ANDA filing constitutes infringement of
United States Patent No. 9, 073, 933 ("the '933
patent"), which relates to plaintiffs'
OxyContin® brand oxycodone hydrochloride. (Id.
at ¶¶ 1-2) OxyContin® is an extended-release
pain medication. (Id. at ¶ 2)
'933 patent, entitled "Oxycodone Hydrochloride
Having Less Than 25 PPM 14-Hydroxycodeinone, " was
issued on July 7, 2015, naming Robert Chapman, Lonn S. Rider,
Qi Hong, Donald Kyle, and Robert Kupper as the inventors.
(Id. at ¶ 30) The '933 patent is directed
to an oxycodone hydrochloride active pharmaceutical
ingredient ("API") with low levels of
14-hydroxycodeinone ("14-hydroxy"), and the
processes for making the oxycodone hydrochloride composition.
('933 patent, col. 1:25-27) 14-hydroxy belongs to a class
of potentially toxic compounds known as alpha, beta
unsaturated ketones ("ABUKs") found in oxycodone
compositions. (Id. col. 6:51-54); Chapman v.
Casner, 315 F.App'x 294, 295 (Fed. Cir. 2009).
July 1, 2014 office action, the United States Patent and
Trademark Office ("PTO") issued a non-final
rejection of then-pending claims 71-90 of the '933 patent
as unpatentable for obviousness-type double
patenting over certain prior art references.
Specifically, the examiner rejected the claims as being
unpatentable over claims 1 to 14 of U.S. Patent No. 7, 683,
072 ("the '072 patent"), claims 1 to 9 of U.S.
Patent No. 7, 674, 799 ("the '799 patent"), and
claims 38 to 55 of U.S. Patent No. 7, 674, 800 ("the
'800 patent;" together with the '072 patent and
the '799 patent, the "low-ABUK patents"), among
others. (D.I. 25, Ex. 8 at 7/1/14 Office Action,
¶¶ 10, 12, 13) The low-ABUK patents share a common
specification and priority date with the '933 patent and,
like the '933 patent, are directed to reducing the amount
of 14-hydroxy in an oxycodone hydrochloride preparation.
response to the obviousness-type double patenting rejection,
plaintiffs filed terminal disclaimers on October 1,
to dispose of the double-patenting rejection, stating that
"[a]pplicants traverse these rejections, but submit
herewith terminal disclaimers ... in an effort to expedite
prosecution." (Id., 10/1/14 Response at 13)
Plaintiffs expressly stated that "[t]hese terminal
disclaimers are being submitted solely for the purpose of
removing the double patenting rejections. The filing of these
terminal disclaimers is neither an admission of the propriety
of the rejections nor an admission that the inventions
claimed in present claims 71-90 are not 'independent and
distinct' from the inventions of the low-ABUK patents.
issued a final rejection of the '933 patent application
on October 31, 2014, rejecting claims 71-90 as obvious under
§ 103 after concluding that it would have been obvious
to one skilled in the art to prepare an oxycodone
hydrochloride composition with a reduced amount of 14-hydroxy
by dehydrating 8a in view of the FDA's instructions to
prepare oxycodone salt with reduced amounts of 14-hydroxy.
('933 patent, 10/31/14 Final Rejection at ¶ 3) The
examiner further noted that parent patent application 11/391,
897 (the "Chapman application") was invalidated
based on an obviousness rejection during an interference
proceeding. On January 29, 2015, the examiner held a
telephonic interview with plaintiffs to discuss the adverse
decision on the claims at issue in the interference
proceedings regarding the Chapman application. Plaintiffs
filed a response after final rejection on March 4, 2015,
further amending the claims to distinguish them from the
Chapman application by independently requiring 8a as an
element of the claimed composition or process. The PTO issued
a notice of allowance of the amended claims 71-90, renumbered
as claims 1-20, on March 23, 2015, after concluding that the
arguments filed on March 4, 2015 were persuasive in
overcoming the obviousness rejections and the addition of the
8a limitation rendered the claims patentably distinct from
the claims at issue in the Chapman interference proceedings.
The Teva Litigation
previously sued Teva Pharmaceuticals, USA ("Teva")
in the Southern District of New York,  alleging
infringement of the low-ABUK patents. In re OxyContin
Antitrust Litig., 994 F.Supp.2d 367 (S.D.N.Y.2014). The
claims of the '799 and '072 patents are directed to
oxycodone hydrochloride, with the '799 patent claiming an
"oral dosage form" of low-ABUK oxycodone
hydrochloride. Id. at 387-88. The asserted claims of
the '800 patent recite a process for preparing an
oxycodone salt substantially free of 14-hydroxy. Id.
at 387. The Southern District of New York held that Teva
infringed all of the asserted product-by-process claims, but
concluded that those claims were invalid for obviousness
pursuant to 35 U.S.C. § 103. Id. at 403
("For purposes of validity, the Court considers only the
product limitations of a claim, not process limitations or
source limitations that add no patentable significance to the
court acknowledged that plaintiffs discovered 8a as the
source of the 14-hydroxy problem, and noted that 8a was
unknown in the prior art, but the court ultimately did not
consider the derived-from-8a language in the low-ABUK patent
claims in reaching its conclusion because process limitations
in product-by-process claims are disregarded in the
obviousness inquiry, and 8a was "largely irrelevant to
the process used by Purdue to obtain the product claimed by
the patents." Id. at 405.
February 1, 2016, the Federal Circuit affirmed the Southern
District of New York's decision regarding the invalidity
of the low-ABUK patents, relying on principles specific to
product-by-process claims and concluding that the district
court did not err in disregarding the 8a limitations in the
obviousness inquiry. Teva, 811 F.3d at 1352-54. The
district court's invalidity determination was therefore
upheld with respect to claims 3 and 19 of the '799
patent, claims 30-34 and 76-79 of the '800 patent, and
claims 1, 4, and 5 of the '072 patent. Id.; In re
OxyContin, 994 F.Supp.2d at 438. On April 1, 2016,
plaintiffs petitioned for rehearing en banc of the Federal
Circuit's decision in the Teva appeal. (D.I. 28,
Ex. 1) Plaintiffs' petition for rehearing en banc was
denied by the Federal Circuit on May 4, 2016, and
plaintiffs' subsequent petition for a writ of certiorari
before the United States Supreme Court was denied on November
14, 2016. (D.I. 33; D.I. 51)
The Chapman Application
low-ABUK patents and the '933 patent are continuations of
the Chapman application, which was filed on March 29, 2006.
In re OxyContin, 994 F.Supp.2d at 388. The Chapman
application recited a "process for preparing oxycodone
hydrochloride having less than 25 ppm [14-hydroxy]."
Id. During an interference proceeding on April 19,
2007 involving claims 96-188 of the Chapman application, the
Board of Patent Appeals and Interferences (the
"BPAI") declared an interference between the
Chapman application and U.S. Patent No. 7, 153, 966
("Casner"). On March 18, 2008, the BPAI found that
independent claim 96 of the Chapman application and the
dependent claims thereof were invalid as obvious in view of
U.S. Patent No. 7, 153, 966 ("Casner"),
and the Federal Circuit affirmed. See Chapman v.
Casner, C.A. No. 08-1427, 315 F.App'x 294, 295 (Fed.
Cir. Mar. 11, 2009); (D.I. 25, Ex. 10, 3/13/08 Order). The
adjudicated Chapman application claims related to a method
for making oxycodone API using a hydrogenation step to remove
14-hydroxy, but they did not require that some of the
remaining 14-hydroxy be derived from the 8a isomer.
Teva, 811 F.3d at 1349. In holding that the claims
at issue were unpatentable under § 103, the BPAI relied
on the lack of any reference in the claims to 8a as the
source of the 14-hydroxy, noting that "[b]ecause the
claims did not specify the source of the 14-hydroxy, any
prior art reference that disclosed conditions under which
either 8a or 80 converted to 14-hydroxy would render the
claim obvious." Id. (citing Chapman,
315 F.App'x at 297). Because the prior art references
disclosed conditions under which 8p converts to 14-hydroxy,
the BPAI determined that the Chapman application claims were
obvious in view of the prior art. Id.
12(b)(6) permits a party to move to dismiss a complaint for
failure to state a claim upon which relief can be granted.
Fed.R.Civ.P. 12(b)(6). When considering a Rule 12(b)(6)
motion to dismiss, the court must accept as true all factual
allegations in the complaint and view them in the light most
favorable to the plaintiff. Umland v. Planco Fin.
Servs., 542 F.3d 59, 64 (3d Cir. 2008).
state a claim upon which relief can be granted pursuant to
Rule 12(b)(6), a complaint must contain a "short and
plain statement of the claim showing that the pleader is
entitled to relief." Fed.R.Civ.P. 8(a)(2). Although
detailed factual allegations are not required, the complaint
must set forth sufficient factual matter, accepted as true,
to "state a claim to relief that is plausible on its
face." BellAtl. Corp. v. Twombly,550 U.S. 544,
570 (2007); see also Ashcroft v. Iqbal, 556 U.S.
662, 663 (2009). A claim is facially plausible when the
factual allegations allow the court to ...